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Evaluating The Effects Of Cimetidine On The Elimination Of PD 0332334 From The Body

Sponsor
Pfizer (Industry)
Overall Status
Terminated
CT.gov ID
NCT00800280
Collaborator
(none)
12
Enrollment
1
Location
2
Arms
1
Duration (Months)
11.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to estimate the effects of multiple doses of cimetidine on the pharmacokinetics of a single dose of PD 0332334 and to evaluate the safety and tolerability of PD 0332334 when co-administered with cimetidine.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

Detailed Description:

Additional Study Purpose Details: Evaluate the effects of multiple doses of cimetidine on the pharmacokinetics (e.g., elimination from the body) of a single dose of PD 0332334.

On February 18th 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Official Title:
A Phase 1, Open-Label, Randomized, Cross-Over Study To Estimate The Effects Of Steady-State Cimetidine On The Pharmacokinetics Of A Single Dose Of PD 0332334 In Healthy Subjects
Study Start Date :
Jan 1, 2009
Actual Primary Completion Date :
Feb 1, 2009
Actual Study Completion Date :
Feb 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Single dose PD 0332334

Drug: PD 0332334
Single 300 mg dose of PD 0332334 immediate release capsules administered orally
Other Names:
  • imagabalin

    		•
    Experimental: Single dose PD 0332334 with steady-state cimetidine

    Drug: PD 0332334
    Single 300 mg dose of PD 0332334 immediate release capsules administered orally on Day 2.

    Drug: cimetidine
    600 mg q 6 hours cimetidine immediate release formulation administered orally on Days 1 through 5.

    Outcome Measures

    Primary Outcome Measures

    1. PD 0332334 area under the curve (AUC) from 0 to infinity (AUCinf) [4 to 6 days]

    2. PD 0332334 AUC from 0 to last quantifiable concentration (AUClast) [4 to 6 days]

    3. Half-life (t1/2) of PD 0332334 [4 to 6 days]

    4. Maximum plasma concentration (Cmax) of PD 0332334 [4 to 6 days]

    Secondary Outcome Measures

    1. Evaluate the incidence, duration and severity of adverse events [4 to 6 days]

    2. Evaluate the discontinuation due to adverse events [4 to 6 days]

    3. Clinical safety labs [4 to 6 days]

    4. ECG [4 to 6 days]

    5. Vital signs [4 to 6 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • healthy

    • male or female adults

    Exclusion Criteria:

    • Current or history of clinically significant medical illness

    • Smokers

    • Illicit drug use

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site New Haven Connecticut United States 06511

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00800280
    Other Study ID Numbers:
    • A5361030
    First Posted:
    Dec 2, 2008
    Last Update Posted:
    Feb 17, 2010
    Last Verified:
    Feb 1, 2010
    Keywords provided by , ,
    cimetidine, PD 0332334, organic cation transporter, OCT2, pharmacokinetics
    Additional relevant MeSH terms:
    Anxiety Disorders
    Cimetidine

    Study Results

    No Results Posted as of Feb 17, 2010